A coronavirus test made by Abbott Laboratories and introduced with considerable fanfare by President Donald Trump in a Rose Garden news conference this week is giving state and local health officials very little added capacity to perform speedy tests needed to control the COVID-19 pandemic.
"That's a whole new ballgame," Trump said. "I want to thank Abbott Labs for the incredible work they've done. They've been working around-the-clock."
Yet a document circulated among officials at the Department of Health and Human Services and the Federal Emergency Management Agency this week shows that state and local public health labs were set to receive a total of only 5,500 coronavirus tests from the giant manufacturer of medical devices, diagnostics and drugs, according to emails obtained by Kaiser Health News.
That number falls well short of the "about 500,000 capacity of Abbott tests that" Dr. Deborah Birx, the White House coronavirus response coordinator, said were in the states and were "not being utilized." Although it is unclear whether she was referring to just the quick test or combining it with another test — one with slower results — that Abbott previously received authorization to sell.
Millions of tests are urgently needed as the virus keeps communities across the country in lockdown and hospitals are overwhelmed with patients.
Labs in all 50 states were set to receive roughly the same number of Abbott's test cartridges and the devices on which they run ― 100 tests and 10 or 15 devices — the document shows, regardless of how many confirmed COVID-19 cases officials had reported in each state.
Abbott Labs spokesperson Darcy Ross on Thursday said the company had shipped tests to customers in 18 states but did not elaborate on how many were public clients or governments as opposed to private health care facilities. Ross also said the document circulated among federal officials showed an "intended purchase by HHS and FEMA" of tests and related instruments.
FEMA referred questions to HHS, whose spokesperson Mia Heck said, "We do not comment on any allegedly leaked documents."
"We can confirm that the federal government is looking to make the initial purchase of a rapid point-of-care test to increase COVID-19 testing capacity in the United States," she said. "Initially, each state will receive 15 point-of-care instruments, and then they will be able to resupply through the commercial market."
Accuracy has been a broad problem in the testing for the novel coronavirus. Abbott Labs declined to address specifics on the clinical accuracy of its tests, which was fast-tracked through the Food and Drug Administration's review process, saying that accuracy data and other performance characteristics will continue to be collected in the field.
State officials are scrambling to obtain Abbott's highly touted machines after it said they could detect the novel coronavirus in as little as five minutes, or give a negative test result in about 13 minutes. That compares with at least 45 minutes to several days to get results from most of the other types of COVID-19 tests being used.
In announcing the test March 27, Abbott said it was "ramping up production to deliver 50,000 ID NOW COVID-19 tests per day" starting this week to the U.S. health care system.
The price of Abbott's stock has jumped 26.5% since March 23.
The document circulated among HHS and FEMA officials March 30 and obtained by Kaiser Health News said 5,500 cartridges ― which translates to 5,500 tests — and 780 devices would be shipped to 55 state and local public health labs all over the U.S. An additional 1,200 tests would go to the Pacific territories. Smaller numbers would be sent to the CDC's lab in Atlanta and the HHS' Strategic National Stockpile.
Abbott has said the company is "working with the administration to deploy the tests to areas where they can have the greatest impact."
But contrary to the document's contents, distribution has been far from even. For example, within days of Abbott's announcing it would ship its rapid test around the country, Detroit Mayor Mike Duggan said he had secured a commitment for five machines and 5,000 tests from the company, making it among the first cities to receive them. The city planned to immediately use them to test police officers and other first responders. A spokesperson for the city didn't respond to questions Thursday about whether Detroit had the tests in hand.
"They tell me it's extremely accurate," Duggan said of the Abbott test Wednesday on CNN, adding it is supposed to be more accurate than the tests already available. "Right now, most of the tests we have are really not 90% accurate until the symptoms have shown themselves."
Demand and hype for new tests developed by private companies surges with each new COVID-19 test that obtains emergency authorization from the FDA, but so far the results have been lackluster.
Since early February, the FDA has granted roughly two dozen emergency authorizations for clinical tests to detect the virus. The tests were developed by governments ― including the CDC and the New York state public health lab — and multiple private companies such as LabCorp, Quest Diagnostics, Roche Diagnostics and Thermo Fisher Scientific.
Yet providers have reported rampant problems with COVID-19 tests giving false negatives, in which the virus is not detected even in an infected person.
Few medical tests are 100% accurate. Any test can have false negatives or false positives. The problem isn't unique to COVID-19 tests.
"False-negative test results — tests that indicate you are not infected, when you are — seem to be uncomfortably common," Dr. Harlan Krumholz, director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation, wrote in a New York Times piece April 1. "Increasingly, and disturbingly, I hear a growing number of anecdotal stories from my fellow doctors of patients testing negative for coronavirus and then testing positive — or people who are almost certainly infected who are testing negative."
Reasons for this can vary. The test itself might not be so good at picking out true cases from false ones. Or maybe it wasn't the test at all, but how the sample was taken or how long it had been since the patient began showing symptoms. Doctors and patients should always consider that a result might not be accurate.
That may be especially true now because the COVID-19 test kits from manufacturers and clinical labs became available under emergency use rules.
Under those rules, manufacturers and labs have to submit documentation to the FDA but don't have to provide as much information as they would under a regular approval process.
Part of the requirement is they show the FDA just how much ― or little — of the virus must exist in the samples before their test can detect it, said Joeffrey Chahine, technical director for the molecular pathology division at MedStar Georgetown University Hospital in Washington, D.C.
They also must show how well the tests specifically pick out the coronavirus, not confusing it with another virus, he said.
By relaxing some of the other information normally required, such as correlating results with the status of actual patients, the test kits could get onto the market sooner. And that's the trade-off.
"This is the downside to loosening the FDA restrictions in that the tests weren't required to go through the same level of quality assurance, the testing of the test, that we would normally see before they go on the market," said Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials. "But I don't think that was a bad decision. This is an emergency."
Detroit, which was supposed to get thousands of Abbott tests this week, had more than 2,800 confirmed COVID-19 cases and 97 deaths as of Thursday evening, and is part of the next wave of emerging hot spots around the country, along with New Orleans and parts of Georgia.
Abbott said it would make tests available to health care providers in "urgent care settings" in the U.S. already using its testing platform, but would not elaborate on specifics.
Public health officials in New York City, Oklahoma and Louisiana said Thursday they had not received the Abbott tests.
"We're aware we didn't have an accurate picture," Shelley Zumwalt, Oklahoma's chief of innovation, said generally of Oklahoma's slow testing start. That has begun to change due to increased testing at Oklahoma State University as well as drive-thru testing sites in over a dozen locations in the state.
Others said that even if they had the Abbott tests, they weren't likely to make much of a dent.
"Each cartridge is one test, and the number of patients you can test depends on how many you use up for training and verification, and quality control, which needs to be run at least once a day," said New York City Department of Health and Mental Hygiene spokesperson Stephanie Buhle. "So 100 cartridges will not go very far."
KHN senior correspondent Julie Appleby contributed to this report.